The U.S. Food and Drug Administration has advised pharmacists to dispense the anticoagulant medication dabigatran etexilate mesylate (Pradaxa) only in the original manufacturer bottles or blister packages because of concerns about product breakdown, according to a MedWatch statement issued on March 30.
In addition, patients should not place Pradaxa capsules in pill boxes or pill organizers, according to the statement. The product should be kept in the original container and should be used within 60 days of opening it.
The storage and handling requirements for Pradaxa, a direct thrombin inhibitor, are listed on the product label and medication guide, but "FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacists," the statement said.
The FDA encourages clinicians and patients to report any adverse events or side effects related to Pradaxa to the FDA MedWatch Safety Information and Adverse Event Reporting Program online or by phone at 1-800-332-1088.